GlaucomaNCT01491867
Continuous Intraocular Pressure (IOP) Measurement and Ability to Detect Treatment Effect
A study testing travoprost 0.003% in people with Glaucoma and Ocular Hypertension, run by Semmelweis University at 2 sites in Hungary.
Trial summary
Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Ocular Hypertension
- What is being tested?
- travoprost 0.003%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesHungary
- Study dates
- Dec 2011to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary open-angle glaucoma (POAG), ocular hypertension(OHT)
- 18 years or older
- C/D <= 0.7
- no risk for visual field damage
- IOP > 22 mmHg
Who cannot join
- Pregnancy and lactation
- Known intolerance to travoprost, topical anesthetic
- Previous ocular surgery at any time
- Previous ocular laser treatment within 1 year
Trial locations and contacts
2 sites in 1 country.
Hungary2 sites
Departement of Ophthalmology
Budapest, Pest County, 1083
Semmelweis University
Budapest, 1083
About this study
Official title: Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement
Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.
Read the detailed description
- Participants are washed ot from all glaucoma medication for 6 weeks
- one eye per participant is investigated (study eye)
- 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days
- for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods
- treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated
- IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively
- Conditions
- Glaucoma, Ocular Hypertension
- Being tested
- travoprost 0.003%
- Keywords
- intraocular pressure
- Medical subject headings
- Glaucoma, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
travoprost 0.003%Drug
Instillation of travoprost 0.003% 1/die in both eyes for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Travoprost arm | Experimental | All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months Receives: Drug: travoprost 0.003% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous intraocular pressure (IOP) measurement
24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor
Measured: 3 months
Secondary outcomes (1)
Continuous intraocula pressure (IOP) Measurement
Reproducibility of intraocular pressure measurements with the Sensimed contact lens sensor methods
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabor Hollo, Semmelweis University
- Investigators
- Gabor Hollo, MD, Principal investigator, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491867
- Sponsor's protocol ID
- 4481/2011
- Status last verified
- Mar 2013
- First submitted
- 12 Dec 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Continuous IOP Measurement and the Influence of Drug Induced IOP Decrease on the Measurement
- ClinicalTrials.gov ID
- NCT01491867
- Acronym / sponsor ID
- 4481/2011
- Conditions
- Glaucoma, Ocular Hypertension
- Keywords
- intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 14 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Continuous intraocular pressure (IOP) measurement with a contact lens sensor may provide more information on the drug-related IOP change than 24-hour IOP measurement with Goldmann applanation tonometry (GAT.
Detailed description
- Participants are washed ot from all glaucoma medication for 6 weeks
- one eye per participant is investigated (study eye)
- 24-h intraocular pressure (IOP) curve is obtained with Goldmann tonometry and Sensimed contact lens sensor tonometry twice, in 14 days
- for Sensimed contact lens curves median values (in arbitrary units), for Goldmann applanation tonometry, mean and SD values are used to characterize the curves, for comparisions % changes are used for the corresponding time periods
- treatment (travoprost 0.005% 1/day) is given to all eyes for 3 months 24-h Goldmann and Sensimed IOP curves are repeated
- IOP curves are determined in arbitrary units and mmHg, respectively, and compared for reproducibility (untreated phase) and relative (%)change (untreated curve vs. under treatment curve) with both methods, respectively
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Travoprost arm | Experimental | Drug: travoprost 0.003%All individuals receive travoprost 0.003% 1/day in both eyes after 6 weeks wash-out for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- primary open-angle glaucoma (POAG), ocular hypertension(OHT)
- 18 years or older
- C/D <= 0.7
- no risk for visual field damage
- IOP > 22 mmHg
Key exclusion criteria (4 listed)
- Pregnancy and lactation
- Known intolerance to travoprost, topical anesthetic
- Previous ocular surgery at any time
- Previous ocular laser treatment within 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| travoprost 0.003%Instillation of travoprost 0.003% 1/die in both eyes for 3 months | Drug | Travoprost arm |
Primary outcome
Continuous intraocular pressure (IOP) measurement
Time frame: 3 months
24-h intraocular pressure (IOP) decrease induced by travoprost 0.003% 1/day as measured with Goldmann tonometry and Sensimed contact lens sensor
1 secondary outcome
Continuous intraocula pressure (IOP) Measurement
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabor Hollo, MD principal investigator
Semmelweis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing travoprost 0.003% in people with Glaucoma and Ocular Hypertension, run by Semmelweis University at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous intraocular pressure (IOP) measurement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2013.